FDA Approvals Predominantly Based on Data Lacking Minority Subjects in Clinical Trials
[Posted on: Thursday, September 28, 2017] Of the 55,000 subjects who participated in cancer clinical trials between 2003 and 2016, only 6% were African-Americans, 5% were Asians, and 3% were Hispanics, creating an abysmal minority representation in the data that formed the basis of FDA approval. There are no legal ways for FDA to push sponsors to increase minority representation in their clinical trials, but there are scientific justifications to have sufficient data from all segments of the population to make accurate prediction regarding utility of a given drug in the entire population. It is ironic that if similar clinical data was included from non-US locations, it would have required the sponsor to conduct a bridging study per ICH E5 before it would have been considered applicable to the US population. But when such data is collected from the US locations, FDA cannot insist on minority data. To be fair, the above numbers are for cancer trials, where due to the life-threatening nature of the indication and unmet medical needs, drugs are approved with “imperfect” data, but a review drugs approved for other indications based on the drug approval snapshots released by FDA, shows a similar deficiency of minority representation in the clinical data. Perhaps there are a few remedies to address this issue. First, most of the cancer patients belonging to minority groups get their treatments done at community clinics, rather than large cancer centers, however, most clinical trials are conducted at large cancer centers. By encouraging sponsors to develop community clinics as clinical trial sites, the potential pool of minority patients for clinical trials could be increased. Second, RWEs can play a bigger role for collecting minority patient data post-marketing to revise the labels appropriately to address minority population data. These two seems to be most promising ways to increase minority participation in clinical trials.
|
|